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Duloxetine for Major Depression in Peri-/Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Eli Lilly and Company
St. Joseph's Healthcare Hamilton
McMaster University
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )
ClinicalTrials.gov Identifier:
NCT00889369
First received: April 27, 2009
Last updated: February 7, 2012
Last verified: June 2009

April 27, 2009
February 7, 2012
May 2009
February 2012   (final data collection date for primary outcome measure)
The effects of response to treatment with duloxetine on brain structure and activation in subjects (peri- and postmenopausal women with MDD). [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00889369 on ClinicalTrials.gov Archive Site
  • Changes in brain activation in remitters versus non-remitters after treatment with duloxetine (remission of depression defined MADRS total score <10 at study end). [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Correlations between changes in brain activation and changes from baseline to study end and menopausal symptoms, depressive symptoms, cognition, quality of life, and clinical global impression (improvement and severity). [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Duloxetine for Major Depression in Peri-/Postmenopausal Women
Duloxetine for the Treatment of Major Depression in Midlife Women: Effects on Brain Structure and Functioning, Mood, and Quality of Life

The main objective of this study is to characterize a range of brain activation symptoms associated with major depression in peri- and post-menopausal women. Also, assessing brain activation before and after the treatment might help to uncover some mechanisms associated with the pathophysiology of depression and menopause.

Women approaching menopause and during the post-menopausal years appear to be at greater risk for developing major depressive episodes. Moreover, this period in life has been associated with significant functional impairment due to the presence/severity of vasomotor symptoms (hot flashes, night sweats), cognitive complaints, and poorer quality of life. In light of recent controversies involving the use of hormone therapies, most physicians and patients are seeking nonhormonal strategies to alleviate menopause-related physical and emotional complaints. Duloxetine has been shown to improve major depressive disorder (MDD) and menopause-related symptoms. To date, the effects of this agent on brain structure and functioning in midlife women with MDD have not been explored. The present study aims to investigate the effects of duloxetine on brain structure and functioning when used for the treatment of a major depressive episode in menopausal women using anatomical magnetic resonance imaging (MRI) and functional MRI (fMRI). In addition, the investigators will examine whether the impact of treatment with duloxetine on vasomotor symptoms, cognition, and quality of life modulate the putative changes in brain structure and functioning.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Duloxetine
Duloxetine, flexible dose, 60-120mg/per day for 8 weeks, following a 2-week placebo lead-in phase to determine study eligibility
Other Name: Cymbalta (duloxetine)
Experimental: A
Use of duloxetine, flexible dose (60-120mg/day) for 8 weeks, following a 2-week placebo lead-in phase
Intervention: Drug: Duloxetine
Frey BN, Hall GB, Attard S, Yucel K, Skelin I, Steiner M, Soares CN. Shift in the brain network of emotional regulation in midlife women: is the menopausal transition the turning point? Menopause. 2010 Jul;17(4):840-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
June 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • peri-/postmenopausal women, aged 40-60 year
  • moderate to severe major depressive episode

Exclusion Criteria:

  • DSM-IV Axis I diagnosis other than MDD
  • contraindications to magnetic resonance imaging
  • treatment-resistent
  • previous failed treatment with duloxetine
  • history of substance abuse or dependence in past year
  • serious suicidal risk
  • use of other psychotropic medications
  • electroconvulsive therapy or transmagnetic stimulation in past year
  • history of allergic reactions to duloxetine
  • significant laboratory abnormalities at baseline
  • severe hepatic impairment
  • end stage renal disease and undergoing dialysis
  • uncontrolled narrow-angle glaucoma
  • uncontrolled or untreated hyper-/hypothyroidism, or abnormal thyroid stimulating hormone concentration
Female
40 Years to 60 Years
Yes
Contact: Stefanie M Attard 905-522-1155 ext 32048 sattard@stjoes.ca
Contact: Benicio N Frey, MD, PhD 905-522-1155 ext 35123 freybn@mcmaster.ca
Canada
 
NCT00889369
WHCC2008-2
No
McMaster University ( Hamilton Health Sciences Corporation )
Hamilton Health Sciences Corporation
  • Eli Lilly and Company
  • St. Joseph's Healthcare Hamilton
  • McMaster University
Principal Investigator: Claudio N Soares, MD, PhD St. Joseph's Healthcare; McMaster University
McMaster University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP